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* = Presenting author

OP017 Long-term outcomes in a cohort of patients with acute severe ulcerative colitis refractory to intravenous steroids treated with cyclosporine or infliximab

D. Laharie*1, A. Bourreille2, J. Branche3, M. Allez4, Y. Bouhnik5, J. Filippi6, F. Zerbib7, G. Savoye8, L. Vuitton9, J. Moreau10, A. Amiot11, J. Cosnes12, E. Ricart13, O. Dewit14, A. Lopez-Sanroman15, J.-L. Dupas16, F. Carbonnel17, G. Bommelaer18, B. Coffin19, X. Roblin20, G. Van Assche21, M. Esteve22, M. Farkkila23, J.P. Gisbert24, P. Marteau25, S. Nahon26, M. de Vos27, J.-Y. Mary28, E. Louis29

1Hopital Haut-Leveque, CHU de Bordeaux, Gastroenterologie, Pessac, France, 2CHU de Nantes, Department of Gastroenterology, Nantes, France, 3CHU de Lille, Department of Gastroenterology, Lille, France, 4Hopital Saint-Louis, Gastroenterologie, Paris, France, 5Hopital Beaujon, Gastroenterologie, Clichy, France, 6CHU de Nice, Gastroenterologie, Nice, France, 7CHU de Bordeaux, Gastroenterologie, Bordeaux, France, 8CHU de Rouen, Gastroenterologie, Rouen, France, 9CHU de Besancon, Gastroenterologie, Besancon, France, 10CHU de Toulouse, Gastroenterologie, Toulouse, France, 11Hopital Henri-Mondor, Gastroenterologie, Creteil, France, 12Hopital Saint-Antoine, Gastroenterologie, Paris, France, 13Hospital Clinic, Gastroenterology, Barcelona, Spain, 14UCL Saint-Luc, Gastroenterologie, Bruxelles, Belgium, 15Hospital ramon y Cajal, Gastroenterology, Madrid, Spain, 16CHU d'Amiens, Gastroenterologie, Amiens, France, 17Hopital du Kremlin-Bicetre, Gastroenterologie, Le Kremlin Bicetre, France, 18CHU de Clermont-Ferrand, Gastroenterologie, Clermont-Ferrand, France, 19Hopital Louis-Mourier, Gastroenterologie, Colombes, France, 20CHU de Saint-Etienne, Gastroenterologie, Saint-Etienne, France, 21University Hospital of Leuven, Gastroenterology, Leuven, Belgium, 22Hospital Universitari Mútua de Terrassa, Gastroenterology, Barcelona, Spain, 23Helsinki University Central Hospital, Gastroenterology, Helsinki, Finland, 24Hospital Universitario de La Princesa, Gastroenterology, Madrid, Spain, 25Hopital Lariboisiere, Gastroenterologie, Paris, France, 26Hopital de Montfermeil, Gastroenterologie, Montfermeil, France, 27Ghent University Hospital, Gastroenterology, Gent, Belgium, 28Hopital Saint-Louis, SBIM, Paris, France, 29Hopital Universitaire de Liege, Gastroenterologie, Liege, Belgium

Background

Cyclosporine (Cys) and infliximab (IFX) are the two second-line drugs for acute severe ulcerative colitis (ASUC) refractory to intravenous steroids. In the CYSIF trial, Cys was not more effective than IFX to achieve short-term remission and to avoid emergent colectomy (Laharie et al. Lancet 2012). However, few long-term data comparing both drugs are available so far. The aim of the present study was to assess long-term follow-up of patients randomized in the CYSIF trial.

Methods

From June 2007 to August 2010, 115 patients with steroid-refractory ASUC defined by a Lichtiger score>10 after at least 5 days of intravenous methyl-prednisolone more than 0.8mg/kg/d have been randomized in 23 GETAID and 6 ECCO centres, to receive Cys (2mg/kg/d for one week, then switched orally during 98 days) or IFX (5mg/kg at weeks 0-2-6). Azathioprine was started at a dose of 2.5mg/kg/d in all patients with clinical response at day 7. The randomized phase ended at day 98. Patients were then followed until death or last news alive up to October 2014. According to treatment allocated at randomization, outcomes were colectomy-free survival and survival without UC relapse leading to systemic therapeutic change (steroids, immunosuppressant or new biologic agent) or colectomy. Time-to-event curves from randomization were derived through Kaplan-Meier method and compared according to randomized treatment through logrank test.

Results

The median follow-up of the entire cohort of the 115 patients (58 assigned to Cys and 57 to IFX) was 5.0 years (IQR: 4.2 - 5.9). Three (3%) patients have died since randomization: a 66-year-old man (Cys) from a myocardial infarction after 4.3 months, a 55-year-old man (Cys secondary treated with IFX) from a pancreatic adenocarcinoma after 21.2 months and a 69-year-old women (Cys) from unknown origin after 28.6 months. Colectomy-free survival rates ± SE (# patients at risk) at 1, 2 and 5 years were respectively 70 ± 6% (39), 65 ± 6% (34) and 61 ± 7% (17) in patients randomized to Cys and 70 ± 6% (39), 68 ± 6% (38) and 65 ± 7% (19) in those randomized to IFX (p=0.86).

Conclusion

In this multicenter long-term follow up cohort of steroid-refractory ASUC patients randomized to Cys or IFX, colectomy-free survival did not depend on initial treatment. These long-term results are confirming good efficacy and safety profiles of these two agents and do not favour one drug over the other.